Condition category
Pregnancy and Childbirth
Date applied
20/08/2007
Date assigned
26/03/2008
Last edited
27/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http:www.rcm-pearls.org

Contact information

Type

Scientific

Primary contact

Ms Sue Macdonald

ORCID ID

Contact details

15 Mansfield Street
London
W1G 9NH
United Kingdom
+44 (0)207 312 3468
Sue.Macdonald@rcm.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07/MRE12/2

Study information

Scientific title

Acronym

PEARLS

Study hypothesis

That the provision of an evidence based training package and its delivery to practitioners will lead to better outcomes for women following perineal trauma.

Ethics approval

Thames Valley Research Ethics Committee, University of Reading. Approved in February 2007.

Study design

Randomised controlled trial using a matched pair cluster design. Maternity units are the unit of randomisation.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.

Condition

Perineal trauma

Intervention

A paired cluster design trial investigating the intervention of an evidence based, standardised training package delivered to midwives and obstetricians, in the assessment and management of perineal trauma. Twenty-four maternity units have been recruited and matched into 12 pairs. The training intervention will initially commence in one unit in each 'pair' (Group A) with it's matched partner continuing to provide usual care (Group B).

All women in participating units will receive written information antenatally, at around 36 weeks. Following birth, further information about the study will be provided, and informed consent obtained on the Labour Ward, or prior to discharge. Women who participate will receive a pack to take home including a covering letter, 10-12 day questionnaire and a Self Addressed Envelope (SAE). Following receipt of the first questionnaire, the second questionnaire will be sent with an SAE at 3 months.

Main study outcomes will be assessed at three months following cascading of the intervention in Group A units. The intervention will then be cascaded among Group B units.

Please use the following contact details to request a patient information sheet:
Sue Tohill/ Linda Lucking
PEARLS Central Office
Academic Unit of Obstetrics & Gynaecology
University Hospital of North Staffordshire
Newcastle Road
Stoke on Trent, ST4 6QG, UK
Linda Lucking:
Tel: +44 (0)1782 552484; Fax: +44 (0)1782 552472; Email: Linda.Lucking@uhns.nhs.uk
Sue Tohill:
Tel: +44 (0)7880 942330; Email: sue.tohill@rcm-pearls.org

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

21/03/2013: The previous primary outcome measures were incorrect due to an error at the time of registration. The correct primary outcome measure is as follows:
Experience of perineal pain on daily activity at 10-12 days post birth.

Previous primary outcome measures until 21/03/2013:
Women's perspectives on what they consider important in the quality and experience of their care:
1. Infection and antibiotic treatment
2. Pain
3. Healing
4. Continence

Secondary outcome measures

21/03/2013: The previous secondary outcome measures were incorrect due to an error at the time of registration. The correct secondary outcome measures are as follows:
1. 10 - 12 days post birth:
1.1. severity of perineal pain
1.2. need for suture removal
1.3. use of pain relief duirng the previous 24 hours
1.4. uptake and duration of exclusive breastfeeding
1.5. perineal wound infection
2. Three months post birth:
2.1. Edinburgh Postnatal Depression Scale (EPDS [14])
score of ≥ 13
2.2 timing of resumption of intercourse
2.3. satisfaction with the perineal repair.
2.4. duration of exclusive breastfeeding

Previous secondary outcome measures until 21/03/2013:
1. Maternal physical and psychological well-being, assessed by the 10 day and 3 month questionnaires:
1.1. Incidence of perineal pain
1.2. Use of postpartum analgesia
1.3. Perineal wound infection
1.4. Uptake and duration of breastfeeding
2. Proportion of women who have an Edinburgh Postnatal Depression Scale (EPDS) score of greater than or equal to 13 at 3 months.

Overall trial start date

01/12/2005

Overall trial end date

01/02/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All women who sustain a second degree perineal tear or episiotomy in a participating unit during the study period will be eligible. To avoid problems with selection biases, overall outcomes for the centre will be ascertained using audit data from birth records. All births during a prespecified period will contribute to these analyses.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1,000

Participant exclusion criteria

1. Women under 16 years of age
2. Non-English speakers
3. Those who have suffered pregnancy loss

Recruitment start date

01/12/2005

Recruitment end date

01/02/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

15 Mansfield Street
London
W1G 9NH
United Kingdom

Sponsor information

Organisation

Royal College of Midwives (UK)

Sponsor details

c/o Mrs Louise Silverton
Deputy General Secretary
15 Mansfield Street
London
W1G 9NH
United Kingdom
+44 (0)207 312 3535
louise.silverton@rcm.org.uk

Sponsor type

University/education

Website

http://www.rcm.org.uk

Funders

Funder type

Charity

Funder name

Health Foundation - Quality Improvement Initiative (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20184764
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24059602

Publication citations

  1. Protocol

    Bick DE, Kettle C, Macdonald S, Thomas PW, Hills RK, Ismail KM, PErineal Assessment and Repair Longitudinal Study (PEARLS): protocol for a matched pair cluster trial., BMC Pregnancy Childbirth, 2010, 10, 10, doi: 10.1186/1471-2393-10-10.

  2. Results

    Ismail KM, Kettle C, Macdonald SE, Tohill S, Thomas PW, Bick D, Perineal Assessment and Repair Longitudinal Study (PEARLS): a matched-pair cluster randomized trial., BMC Med, 2013, 11, 209, doi: 10.1186/1741-7015-11-209.

Additional files

Editorial Notes